Tuesday, August 30, 2016

In an article published Sunday in the Las Vegas Sun, a health official blasted the e-cigarette companies for spreading misinformation. She is quoted as saying: "We are dealing with a (vapor industry) marketing machine that spits out misinformation."

In the article, that same health official is quoted as stating: "At the end of the day, what comes off an electronic cigarette is an aerosol that we know causes cancer."

Previously, the same health official told the public that we don't know whether e-cigarette aerosol contains fewer chemicals and carcinogens than tobacco smoke (even though tobacco smoke contains more than 10,000 chemicals and more than 60 carcinogens).

The Rest of the Story

This health official is certainly in line for a hypocrisy award. She blasts the e-cigarette companies for spreading misinformation without actually citing any examples. Then she turns around and blatantly lies to the public by claiming that e-cigarette aerosol is known to cause cancer.

There is no evidence that vaping causes cancer, and smokers who switch from smoking to vaping experience a dramatic decrease in their exposure to carcinogens.

This public statement is likely to do significant public health damage. It may well convince smokers who might otherwise have tried to quit using e-cigarettes to continue smoking instead. After all, if vaping causes cancer, then what's the point of switching? And this misguided advice may also cause many ex-smokers to return to smoking. After all, what's the point of continuing to vape if it's known to cause cancer. You might as well smoke and enjoy the real thing.

For this reason, I see this as an example of public health malpractice. It represents a negligent communication on the part of a public health official which is almost certain to cause substantial public health damage.

Monday, August 29, 2016

The results of a new study published late last week in the journal Tobacco Control strongly refute the hypothesis that e-cigarettes are a gateway to smoking and that vaping is re-normalizing smoking among youth.

(See: Miech R, Patrick ME, O'Malley PM, Johnston LD. What are kids vaping? Results of a national survey of US adolescents. Tob Control. Published online ahead of print on August 25, 2016. doi: 10.1136/tobaccocontrol-2016-053014.)

The study reports results from the 2015 Monitoring the Future survey, as study of a nationally representative sample of U.S. youth in grades 8, 10, and 12. The sample size was approximately 15,000.

The key result of the study was that the vast majority of youth who had used electronic cigarettes reporting having used e-liquids that only contained flavoring, but not nicotine. A much smaller proportion of youth reported using e-liquids containing nicotine. For example, among 12th graders who had ever vaped, 65% reported using e-liquids with just flavoring, while just 22% reported using e-liquids containing nicotine. Overall, fewer than one-fourth of adolescents who had experimented with e-cigarettes reported using nicotine-containing vaping products.

The study summarizes its main finding as follows: "Among students who had ever
used a vaporiser in their life, the
portion who used ‘just flavouring’ the last time they vaped was greater
than all other
substances combined. This response was
markedly consistent across grades and was reported by 65–66% of students
in 12th, in
10th and in 8th grades. ... The percentage
who vaped ‘just flavouring’ at last use
was also high among students who used a vaporiser in the past 30 days,
at a prevalence
of 59% or higher in all three grades."

The study concludes that: "the majority of US youth who use vaporisers and e-cigarettes do not vape nicotine."

The Rest of the Story

The results of this study have three major implications.

First, the findings bring into question the language that anti-tobacco groups and health agencies are using in talking about youth e-cigarette use. These groups and agencies, including the CDC, are calling e-cigarette use a new form of "tobacco use." This is inaccurate in the first place because e-cigarettes do not contain any nicotine. But even if one allows for the use of the term tobacco product because the nicotine in e-cigarettes is derived from tobacco, calling e-cigarettes that youth use a tobacco product is still inaccurate. Most youth are apparently using e-liquids devoid of nicotine. Moreover, to include e-cigarette use under the category of "tobacco use," as the CDC has been doing, is a practice that needs to end.

The authors of the study go further and suggest that even the term "electronic nicotine delivery system" is inaccurate. They write: "these results suggest the need to
reconsider the term ‘ENDS’ to denote vaporisers and e-cigarettes, at
least among US adolescents.
The term stands for ‘electronic
nicotine delivery system’, which seems inaccurate for the description of
a device that the
majority of youth do not use to vape
nicotine."

The second major implication of these findings is that they add to the evidence that e-cigarettes are not a gateway to tobacco use and that youth don't even look at these products as being a form of smoking. It appears that the major factor related to youth e-cigarette experimentation is the vaping experience itself (including the flavoring), rather than the nicotine.

This leads us to the third implication of these findings, which is that the study adds to the already strong evidence that vaping is not re-normalizing smoking, but quite the opposite: it is helping to further de-normalize smoking. While anti-tobacco groups and health agencies like the FDA and CDC have been spewing propaganda whose effect is to make kids think of e-cigarettes like they think of smoking, if left to their own "devices," youth do not tie vaping to smoking and therefore, vaping plays no role in re-normalizing smoking.

Ironically, it is the CDC and other health and anti-tobacco organizations that are putting it into kids' heads that vaping is essentially the same as smoking, or at least should be viewed in a similar way. This is the opposite of what we should be doing. Again, and ironically, it is those who are promoting vaping who are clearly presenting these products as being different from traditional cigarettes and therefore creating a climate in which vaping can further de-normalize smoking.

By repeatedly hammering home the perception that vaping is just another hazardous form of tobacco use, anti-tobacco groups and health agencies like the CDC and FDA are doing more damage than good.

Thursday, August 25, 2016

A new study out of the Roswell Park Cancer Institute has demonstrated that smokers who switch to e-cigarettes experience an immediate and drastic reduction in their levels of carcinogens and toxins. This reduction is seen as early as one week after making the switch to e-cigarettes and for some toxins, increases further at two weeks. Subjects were not followed longer than two weeks to determine whether these levels drop further after that point.

The study measured urine levels of 17 biomarkers of tobacco smoke exposure in 20 adult smokers, before and after they switched (partially or completely) to e-cigarettes.

The lead author of the study - Dr. Maciej Goniewicz, Assistant Professor of Oncology in the Department of Health
Behavior at Roswell Park - concluded: "To our knowledge, this is the first study with smokers to demonstrate
that substituting tobacco cigarettes with electronic cigarettes may
reduce exposure to numerous toxicants and carcinogens present in tobacco
cigarettes. This study suggests that smokers who
completely switch to e-cigarettes and stop smoking tobacco cigarettes
may significantly reduce their exposure to many cancer-causing
chemicals."

Most importantly: "The decline in toxicant levels was similar to the decline seen among tobacco users who quit smoking."

The paper explains that: "the observed decline in various urine toxicant biomarker levels in our study was similar to decline among smokers who have quit smoking completely and did not substitute with any other product. This observation suggests that e-cigarettes are not a significant source of exposure to those toxicants."

The reduction in urine levels of several of the toxicants and carcinogens among smokers who switched completely to e-cigarettes (i.e., quit smoking) were particularly striking. For example, at two weeks, levels dropped by 98% for 1,3-butadiene, 70% for crotonaldehyde, 87% for benzene, and 89% for acrylonitrile. Exhaled carbon monoxide levels dropped by 82% among these subjects.

The Rest of the Story

This study adds to the growing body of evidence that not only are e-cigarettes much safer than cigarettes but quitting smoking using e-cigarettes leads to immediate and dramatic improvements in health.

If anti-tobacco groups have any scientific integrity, this should put an end to their misleading propaganda claiming or implying that vaping is just as hazardous as smoking, that switching from smoking to vaping has not been shown to have health benefits, and that we don't know enough about the health effects of vaping to conclude that it is safer than smoking.

However, I suspect that these scientific findings will have little or no effect on the statements of anti-tobacco groups because I don't believe they are interested in the science. They are so threatened by the existence and success of vaping that they will ignore the facts in order to protect their long-standing ideology and perspective. That something which looks like smoking could possibly be beneficial for health is not within the mindset of these groups. That something which involves the inhalation of nicotine and which brings pleasure to many people might not make them sick or kill them is also not acceptable, and any such suggestion must be immediately exterminated.

From now on, we should refer to switching from smoking to e-cigarettes as "quitting smoking." From a health perspective, there does not appear to be a significant difference, at least in the short-term. The question "What do you call a person who switches from real cigarettes to e-cigarettes?" should be answered "An ex-smoker."

There is simply no evidence-based reason to discourage smokers from using e-cigarettes, especially if they have been unsuccessful quitting using the "FDA-approved" methods.

Recommendations from physicians that smokers not be encouraged to try e-cigarettes - like this one from Dr. Adam Goldstein at the University of North Carolina - are not scientifically tenable and are destructive to the protection of the public's health.

Wednesday, August 24, 2016

Dr. Stan Glantz has posted a commentary on his blog in which he asserts that the results of a paper published earlier this summer in the Journal of the American College of Cardiology demonstrate that "the [cardiovascular] effects of e-cigarette use are nearly as big as smoking."

Dr. Glantz nicely summarizes the major study results: "One of the many ways that smoking damages the cardiovascular system is
by stiffening major blood vessels. How stiff the aorta (the big vessel
leading directly out of the heart) is can be measured by how fast the
pressure wave moves down the aorta, the pulse wave moving faster when
the aorta is stiffer. Following use of an e-cigarette for just 5
minutes, the pulse wave velocity increased by about 40% as much as
smoking a conventional cigarettes and about 80% after 30 minutes of use."

The Rest of the Story

I agree that the study reveals that vaping has acute adverse effects on the cardiovascular system. However, I would not describe the effects of vaping as being "nearly as big as smoking." After all, smoking causes heart disease and stroke. All this study demonstrates is that vaping causes acute arterial stiffness. The study does not demonstrate whether over time, this acute effect will actually translate into vascular disease.

The results of the study are not at all surprising, since we already knew that nicotine itself causes arterial stiffness. Thus, it would have been shocking if vaping was not found to increase arterial stiffness.

What Dr. Glantz failed to note was that the adverse effect of vaping on arterial stiffness disappeared within 30 minutes after discontinuation of vaping. In contrast, the adverse effect of smoking was sustained at the 60 minute mark. The effect is reversible, and therefore it cannot be assumed that vaping will cause sustained injury that over time will lead to cardiovascular disease. It would take decades of vaping before it is even plausible that vascular disease could occur. It is quite premature to conclude that the effects of vaping are "as bad as smoking."

There are some other important things that Dr. Glantz failed to note and which anti-vaping groups will not tell you. For one, drinking coffee also causes arterial stiffness. But coffee consumption is not known to be associated with the development of cardiovascular disease and no one would state that the cardiovascular effects of drinking coffee are "as bad as smoking," even though caffeine, like nicotine, causes changes in arterial compliance acutely that are similar to the acute arterial compliance changes seen with smoking.

Sadly for my students, taking an exam has also been shown to increase aortic stiffness, just like smoking. However no one would argue that the cardiovascular effects of taking an exam are as bad as smoking. Hopefully none of my students has read Dr. Glantz's post because I can just see them trying to get out of my next exam by claiming that it will cause aortic stiffness and their doctor has advised them against any exposures that have adverse cardiovascular effects.

Watching a suspense movie also increases aortic stiffness, but no one would argue that watching a movie has cardiovascular effects that are "as bad as smoking," and as far as I know, no one has claimed that watching scary movies is a risk factor for cardiovascular disease. I didn't see too many people keeling over with heart attacks when watching Anthropoid.

High intensity resistance training also increases aortic stiffness, but I don't see a sign in the gym warning people that this type of exercising has cardiovascular effects that are "as bad as smoking."

Listening to classical or rock music actually decreases aortic stiffness, although I find that listening to Justin Bieber increases my annoyance level to extremes and I'm sure my aorta is as stiff as a lead pipe under those conditions. But I'm aware of no evidence that Beliebers have increased rates of cardiovascular disease.

Watching World Cup soccer also increases vascular resistance but we don't tell soccer fans that they are engaging in a habit that has health effects that are as bad as smoking.

I am not trying to downplay the finding that vaping results in acute, adverse changes in vascular function that - if repeated and sustained over decades - could plausibly increase cardiovascular disease risk. However, it is premature to draw such a conclusion and disingenuous to tell the public that the cardiovascular effects of vaping as as bad as those of smoking.

Tuesday, August 23, 2016

According to an article in the Arizona Daily Star, a youth tobacco control advocate is going around telling other youth that vaping can kill you. He is quoted as stating:

“Many think it’s just water vapor when really there’s nicotine, and
nicotine is known to be an addictive chemical — it’s a natural pesticide
and if your body takes in enough of it, it can kill you.”

The Rest of the Story

The story of a random youth from Arizona spreading false information about the risks of vaping would not ordinarily make headlines at the Rest of the Story. But when I first started reading this article, something struck me as odd. It seemed unbelievable that an intelligent 16-year-old high school student would, on his own, come to the conclusion that vaping can be fatal because nicotine is a "pesticide" and inhaling too much nicotine could cause death. It seemed especially odd when I reasoned that this youth is not exactly seeing his peers drop dead left and right from too much vaping. Also, the line about e-cigarettes delivering more than just water vapor sounded a bit too familiar. Without reading any further in the article, I came to the immediate conclusion that this must be a youth who was indoctrinated by an anti-smoking group.

Sure enough, when I continued reading the article, the rest of the story became clear. Indeed, this youth was literally indoctrinated by the Campaign for Tobacco-Free Kids after attending a youth advocacy symposium:

"Duarte, a member of the Cochise County
Youth Health Coalition, recently returned from a trip to Washington,
D.C., where he was advocating for the need for action to protect kids
from newer tobacco products like electronic cigarettes and flavored
cigars, which also have become popular. He
was one of 21 youths from across the country participating in the
Campaign for Tobacco-Free Kids’ Youth Advocacy Symposium, where he met
with Arizona Rep. Martha McSally and the staffs of Sens. Jeff Flake and
John McCain."

Now it all makes sense. It appears that in fact this youth did not come to this conclusion himself but was taught this false information during his indoctrination by the Campaign for Tobacco-Free Kids. Now he is spouting their propaganda word-for-word.

It is sad to observe that the Campaign is using youth to spread its propaganda designed to demonize electronic cigarettes and obscure the public's appreciation of the severe hazards of smoking by equating its risks only with those of using a product which is "not just water vapor."

While I completely support youth advocacy, it is essential that we be honest with youth and tell them the complete story, not just partial truths, or in the case of the Campaign for Tobacco-Free Kids - complete lies.

Saturday, August 20, 2016

A new study published yesterday in the journal Tobacco Control purports to show that e-cigarettes are a gateway to smoking. The study followed 1,136 nonsmoking youth in grades 9 to 11 in Hawaii for one year to determine which youth initiated smoking during this follow-up period. Baseline surveys were conducted in 2013, and follow-up surveys were conducted in 2014. Rates of smoking initiation were compared between youths who had used e-cigarettes at baseline and those who had not used e-cigarettes. The study found that youths who had used e-cigarettes were significantly more likely to initiate smoking and that this association was stronger for youth who had a lower propensity to start smoking. Based on that finding, it concluded that e-cigarettes are a gateway to smoking.

Propensity to smoking was assessed by measuring rebelliousness, parental support, and intentions to smoke.

The study concludes as follows: "This study provides evidence that ecigarettes are recruiting lower risk adolescents to smoking, which has public health implications."

The Rest of the Story

The rest of the story is that this study does not actually provide evidence that e-cigarettes are recruiting youths to smoking. What it shows is that experimentation with e-cigarettes is a much more sensitive marker of propensity to smoking than simply assessing rebelliousness or parental support or intentions to smoke.

The major problem with the study is that it does not examine whether or not youth who experiment with e-cigarettes become addicted to vaping and then progress to smoking, which would be indicative of a gateway effect. Instead, it compares youth who have simply tried e-cigarettes with youth who never even had a puff of an e-cigarette. The study does not document that any of the youth who experimented with e-cigarettes actually became regular vapers or that they were addicted to vaping before progressing to smoking.

In fact, the paper hides a critical piece of information: although 29% of the high school students in the sample had experimented with e-cigarettes, only 2% were using them more than once a week. Therefore, at least 98% of the e-cigarette experimenters were clearly not addicted to vaping and could not be considered regular vapers.

The key problem is that the study did not determine the trajectory of e-cigarette use prior to the initiation of smoking. It is entirely possible that many of the youth who had experimented with e-cigarettes actually failed to take up vaping and that because of this failure, they started smoking. Thus, the study results are entirely consistent with the conclusion that vaping is protective against smoking initiation.

There is an alternative explanation for why youth with a lower propensity to smoke who experimented with e-cigarettes were more likely to start smoking. Namely, what this shows is that e-cigarette experimentation is a much more sensitive marker of propensity to smoke than the measure used in the study, which relied on measures of rebelliousness, parental support, and future intentions to smoke.

In fact, if you look carefully at Figure 1, you'll see that among youth who used e-cigarettes at least 5 times at baseline, propensity to smoke failed to predict smoking initiation risk. Having experimented with e-cigarettes was a much better marker of propensity to smoke than the propensity measure actually used in the study.

Let me provide an analogy to help explain this. Suppose that you were interested in studying whether using marijuana is a gateway to smoking. You do a study showing that nonsmoking youth who experiment with marijuana a few times are more likely to have initiated smoking one year later. Does this provide evidence that marijuana is a gateway to smoking?

I would argue that it doesn't. There is another plausible explanation for the study results, which is that marijuana experimentation does not cause youth to smoke, but merely is a marker for a risk-taking personality trait that predisposes to smoking.

And if we were to find that the relationship between marijuana experimentation and smoking initiation were stronger among youth who had a lower propensity to smoke, would that demonstrate that the observed relationship is because marijuana use causes kids to smoke, rather than that it is a marker for an increased baseline propensity to smoke? No, it would not. It could be that experimentation is just a much more sensitive marker of propensity to smoke because it shows whether or not a youth has actually taken up a drug-related risk-taking behavior.

If a youth has taken up a drug-related risk-taking behavior, how could it possibly be that this youth is not more likely to also take up another drug-related risk-taking behavior?

In other words, it would be absolutely shocking if we found that youth who try e-cigarettes are not more likely to initiate smoking. I would have predicted the results found in this new study before the study was even conducted, and I would have bet my professional reputation on the fact that the study would indeed find an increased risk of smoking among youth who had experimented with e-cigarettes and that this risk would be greater among youth with a lower propensity to start smoking as measured by less definitive indicators such as parental control and general level of rebelliousness, or even stated intention to smoke.

To be clear, the rest of the story is that this new study provides no evidence that e-cigarettes are a gateway to smoking. Instead, it confirms that actual drug-related risk-taking behavior is a much better predictor of other drug-related risk-taking behavior than simply asking a kid if he thinks he will try another drug in the future or asking a kid how rebellious he is or how much his parents support him.

What would it take to actually provide evidence that marijuana use is a gateway to smoking?

Two things.

First, one would have to examine the trajectory of marijuana use. If youth who experiment with a few joints then go on to become regular marijuana users, and then over time progress to "harder" drugs like cigarettes, that would provide some evidence of a gateway effect of marijuana. But the present study presents no evidence that e-cigarette experimenters go on to become regular vapers, and then over time progress to cigarettes.

Second, one would have to provide at least some evidence of a mechanism by which the use of marijuana creates changes that then causally lead to smoking.

In the case of marijuana, there is some evidence for such an effect. As explained by the National Institute on Drug Abuse: "Early exposure to cannabinoids in adolescent rodents decreases the
reactivity of brain dopamine reward centers later in adulthood.46
To the extent that these findings generalize to humans, this could help
explain the increased vulnerability for addiction to other substances
of abuse later in life that most epidemiological studies have reported
for people who begin marijuana use early in life.47 It is also consistent with animal experiments showing THC's ability to "prime" the brain for enhanced responses to other drugs.48 For
example, rats previously administered THC show heightened behavioral
response not only when further exposed to THC but also when exposed to
other drugs such as morphine—a phenomenon called cross-sensitization.49"

In the case of e-cigarette experimentation, there is no evidence of a mechanism by which use of a highly flavored and sweet-tasting product would lead youth to be dissatisfied and craving for a harsher and less tolerable alternative. In fact, conceptually, there is evidence that regular vaping is likely to be protective against smoking initiation. The existing evidence suggests that most youth vapers are doing so because they enjoy the flavorings, rather than because they are deriving pleasure from any kind of nicotine hit or reward. The Monitoring the Future survey revealed that the majority of youth who use e-cigarettes report that they vape flavored e-liquids that do not contain nicotine. It appears, then, that nicotine is a minimal if not non-existent reason for youth e-cigarette experimentation. Thus, the hypothesis that youth use e-cigarettes, become addicted to the nicotine, are not satisfied enough with vaping and feel the need for something more hard-core, and therefore progress to cigarette smoking is dubious at best, and at worst, is a little on the ridiculous side.

At very least, it would necessary to demonstrate that a significant number of youth who experiment with e-cigarettes are in fact addicted to nicotine. So far, I'm not aware of a single study which has demonstrated that a single youth vaper is addicted to nicotine. We're not even sure that a substantial proportion of youth who vape are using nicotine-containing products in the first place. Nor is there any evidence that the delivery of nicotine from the products that youth are using is sufficient to create and sustain nicotine addiction. In fact, studies of nicotine delivery indicate that with most e-cigarettes, it is not conducive to creating addiction because there is no significant spike in blood nicotine levels such as to create a "hit" or a psychological reward that would lend itself to a propensity for addictive behavior.

There is a second problem with the study which deserves mention, although even without this second problem the study conclusion would be invalid.

This second problem is that smoking initiation was measured by any experimentation with cigarettes, even if just a puff. So many of the youth in the sample may have puffed on a single e-cigarette at baseline and then puffed on a single cigarette some time over the next year and that would be considered as providing evidence that e-cigarettes are a "gateway" to smoking. I provide this example only to show how flimsy the study conclusions are. In reality, I would actually expect to see higher rates of actual smoking initiation and sustained, regular smoking among youth who at baseline had experimented with e-cigarettes, and that would not provide evidence of a gateway effect. In fact, such a finding would be entirely consistent with the hypothesis that it is the failure of youth to become regular vapers that predisposes them to try smoking. It is still entirely possible that youth who become regular vapers are somewhat immune from smoking because it becomes very difficult to switch from a sweet, flavored product to a harsh, real cigarette like a Marlboro.

Although I disagree with the study conclusions, I do want to note that I agree with the overall study recommendations, which include providing education to youth about the potential health risks of both vaping and smoking, taking efforts to keep e-cigarettes out of the hands of youth, and restricting marketing of vaping products to youth. These actions should be taken regardless of whether e-cigarettes are a gateway to smoking or not.

Nonetheless, I'm afraid this study is going to do significant damage because anti-smoking groups are going to use this to convince the public and policy makers that e-cigarettes are a gateway to smoking, and this is going to lead to the continued promulgation of irrational policies that promote cigarette smoking by discouraging vaping. The media are already reporting this study as having proved that e-cigarettes are a gateway to smoking. It's almost impossible to get the cat back in the bag. Even if people now know "the rest of the story."

Thursday, August 18, 2016

A physician with the Johns Hopkins All Children's Hospital, who is apparently a strong opponent of vaping, has advised parents to lie to their children about the hazards of smoking in order to dissuade them from using electronic cigarettes. Specifically, she urges parents to downplay the hazards of smoking so that kids will think that vaping is just as dangerous as smoking and will therefore avoid it at all cost.

According to a post on the hospital web site: "E-cigarettes may appear to be a safer way to smoke, but they are just as dangerous for children. ... Scientists are just beginning to see the dangerous effects of vaping, such as cancer. ... If parents use these products, they are strongly recommended to quit
and keep all smoking accessories out of reach, especially for younger
children. “Most importantly, parents should talk to their children about the
dangers and harmful side effects of e-cigarettes and others drugs,” says
Dr. Dawkins. “Parents should also consider vaping just as dangerous as
smoking cigarettes when talking to their teens about the dangers of
tobacco use and smoking.”"

The Rest of the Story

While I agree that children should be urged not to use electronic cigarettes, by no means do I agree that parents should lie to their children about the relative hazards of vaping vs. smoking in order to scare their kids away from these products. What this physician is suggesting is that parents should actually downplay the hazards of smoking by equating them with those of vaping, in the hope that this will scare kids away from e-cigarettes.

This advice is inappropriate not only because we in public health and medicine should never encourage parents to lie to their children about health risks, but also because it undermines decades of public education about the severe health hazards of cigarette smoking. If cigarettes are no more hazardous than vaping products, then cigarettes aren't all that bad for you. After all, Vuse and Mark Ten e-cigarettes, along with several other brands, have been documented not to contain any detectable amounts of hazardous chemicals and appear to be associated with only minimal risks. Do we really want our next generation to believe that smoking is no worse than inhaling a few flavorings, devoid of any tobacco and not involving any combustion?

As much as we might want to dissuade youth from vaping, I don't believe we can justify asking parents to lie to their children in order to try to accomplish this. Moreover, I don't believe that we need to rely on lies. I think the truth is sufficient. I also think that telling kids the truth will be more effective than lying to them. In addition, parents risk losing their kids' trust if it becomes apparent that they are lying (as it certainly will to many kids who aren't going to be tricked into believing that inhaling from a tube that contains no tobacco is more dangerous than smoking).

To make matters worse, the hospital itself is lying to the public by stating that vaping causes cancer. There is no evidence to support this. Vaping has never been shown to be associated with cancer in any animal or in any clinical study. There is no more support for claiming that vaping causes cancer than there is for telling the public that furniture causes cancer or that eating peanut butter causes cancer.

It is difficult to understand this apparently extreme need among vaping opponents to lie. But perhaps this need becomes clearer when you consider how little vaping opponents have to support their position. About the worst thing they can truthfully tell the public is, as the Johns Hopkins All Children's Hospital says in its post, that e-cigarettes "are not harmless." That isn't a very strong indictment. You could say the same thing about drinking coffee, eating Vienna Fingers, or playing Pokemon Go.

Therefore, all vaping opponents can do if they want to scare people and to demonize vaping is to lie about it. I find it unfortunate that in the process, they are downplaying the hazards of smoking and undermining decades of public education and awareness. Most unfortunate, however, is the fact that they are risking losing the public's trust to accomplish their aims.

Tuesday, August 16, 2016

In apparent desperation because the actual facts do not support their vigorous opposition to vaping, anti-vaping advocates continue to simply make up the "facts" as they go along.

Just last week, a professor at Eastern Tennessee State University was quoted in an article in the Johnson City Press as stating that the increase in youth e-cigarette use means that vaping is bringing in new smokers.

According to the article: "Dr. Hadii Mamudu, an East Tennessee State University assistant
professor in the school’s College of Public Health, is a world-wide
recognized expert on this topic. One of his biggest evidence-based
concerns, which have been somewhat addressed in the new regulations,
pertain to the unsettling trend that more youth are taking to
e-cigarette use, whereas they might not have come into tobacco use
otherwise. “A North Carolina survey suggests that youth use rates increased from
1.1 percent to about 8 percent between just 2011 and 2013,” Mamudu
said. “It’s very, very quick. And that’s troubling that it’s bringing in
new smokers.” ... It’s partly generational, Mamudu said, and it’s frustrating that when
tobacco experts were making progress against tobacco use in recent
decades, e-cigarettes came along to cut into their gains."

The Rest of the Story

I am aware of no evidence that vaping is bringing in new smokers. What it is doing is bringing in new vapers. But there is no evidence that vaping is easing the transition to becoming a smoker. If anything, the evidence suggests the opposite. While e-cigarette use skyrockets, youth smoking has plummeted to its lowest historical level.

It is not even conceptually reasonable to suggest that e-cigarette use brings in new smokers. The e-cigarettes that youth are using are heavily flavored products and after getting used to the sweet and tasty flavorings, it is difficult to imagine that a youth would then find a Marlboro attractive. The truth is that youth who really do take up vaping are likely going to find it much more difficult to transition to smoking.

But the lack of evidence - either empirical or conceptual - is not stopping vaping opponents from simply making up the facts as they go along. Apparently, the truth is not enough to support their vigorous opposition to vaping. When the truth is not on your side, your only resort is to manufacture, make up, or distort the facts to support your position.

There is another possibility as well. It is possible that when he says that e-cigarettes are bringing in new smokers, the professor means that vapers are smokers - in other words, that vaping is a form of smoking. But that is obviously false, as vaping involves no combustion, produces no smoke, and does not even involve the use of tobacco.

Either way, anti-vaping advocates continue to intentionally mislead and deceive the public. It is unfortunate that vapers cannot trust tobacco control and health groups to provide accurate information. They can't even trust national health agencies like the CDC and FDA. The only place they can turn for accurate information is to the vaping community itself.

Monday, August 15, 2016

Last Monday, the U.S. Food and Drug Administration (FDA) committed one of the most bone-headed blunders I have ever witnessed in public health. The agency's Center for Tobacco Products (CTP) banned all safety improvements for electronic cigarettes and vaping products.

This means that e-cigarette and e-liquid manufacturers can make no further improvements in the safety of their products, even if they become aware of severe and potentially life-threatening product defects.

NOTE: This is not a parody, and you are not reading The Onion. This is the actual regulation that the FDA put into effect on August 8th.

In order to make a safety improvement, an e-cigarette manufacturer would have to complete a burdensome and extensive pre-market tobacco application (PMTA), a process that is expected to take two years and to cost at least $5 million. This is obviously not an expense that more than 4 or 5 of the companies could afford. And even if they could afford the capital expense, it would still be another 2 years that their known defective product is required to stay on the market.

For example, let's say that a company tests its e-liquid using a more sensitive mass spectrometer and finds that it contains diacetyl, a chemical that has been linked to "popcorn lung," a severe and possibly fatal lung disease. The FDA regulations prohibit the manufacturer from removing the diacetyl from the e-liquid. If the company changes the ingredients of the e-liquid, it would be considered a "new" tobacco product and would therefore require a PMTA. The FDA regulations essentially require the company to continue selling its product with this toxic chemical, rather than to remove it.

Similarly, suppose that a company finds that by switching to a dual coil system, it can lower the unit's heating level and eliminate the formation of formaldehyde, a known carcinogen. The FDA regulations prohibit the manufacturer from making this change. In essence, the FDA is forcing the company to continue selling its product with the carcinogen, rather than to take this simple design measure to eliminate the carcinogen.

You may be wondering: How can this possibly pass Constitutional muster? How can the FDA possibly justify a regulation that - on its face - harms the public health by preventing safety improvements in a consumer product?

The answer is that it cannot justify the regulation. There are only costs - and no benefits - of the prohibition on safety improvements. The FDA has clearly violated the Administrative Procedure Act by failing to provide a cost-benefit analysis, and the regulation is arbitrary and capricious and serves no legitimate government purpose. But the legal challenges to this regulation will take months (if not years), and in the meantime, the regulation's prohibition on safety improvements remains in effect (unless a judge issues an injunction that prevents enforcement of the regulation while it the issue is being litigated).

The Rest of the Story

To me, the most surprising aspect of this story is not so much that the FDA blundered by enacting a regulation that immediately and irreparably harms the public's health. The most surprising part of the story is that this move was supported by virtually every national, anti-tobacco organization, including the American Lung Association, which actually praised the ban on safety improvements in e-cigarettes.

How could a ban on safety improvements possibly be a good thing for public health?

The only thing that the American Lung Association is protecting is smoking and continued tobacco use. They lobbied for a policy that actually inhibits the transition away from tobacco products and helps to preserve cigarette sales and cigarette company profits.

Jacob Sullum succinctly summarized the problem in a column last week at Forbes.com:

"The Food and Drug Administration’s e-cigarette regulations,
which took effect this week, immediately struck two blows against
public health. As of Monday, companies that sell vaping equipment and
the fluids that fill them are forbidden to share potentially lifesaving
information about those products with their customers. They are also
forbidden to make their products safer, more convenient, or more
pleasant to use. The FDA’s censorship and its ban on innovation will discourage
smokers from switching to vaping, even though that switch would
dramatically reduce the health risks they face. That effect will be
compounded by the FDA’s requirement that manufacturers obtain its
approval for any vaping products they want to keep on the market for
longer than two years. The cost of meeting that requirement will force
many companies out of business and force those that remain to shrink
their offerings, dramatically reducing competition and variety. All of this is unambiguously bad for consumers and bad for public health."

The rest of the story is that e-cigarettes pose such a threat to the paradigm of tobacco control advocacy that national organizations like the American Lung Association have completely lost their judgment. The sheer fear of a non-tobacco-containing product that could provide satisfaction to smokers without killing them is too much to bear. Ironically, it is the efficacy and health advantages of e-cigarettes that represent the greatest perceived threat to the survival of the mantra of groups like the American Lung Association. And they are fighting to protect that mantra, even at the expense of abandoning the fight against tobacco-related disease and death.

Tuesday, August 02, 2016

According to an article in yesterday's Winston-Salem Journal, the head of the FDA's Center for Tobacco Products (CTP) told the hundreds of thousands of ex-smokers in the U.S. who successfully quit smoking by switching to vaping that: "there is no definitive support of e-cigs playing a cessation role."

In other words, Mr. Zeller--the CTP director--is telling vapers that they don't exist, that their experiences never happened.

This will come as news to the hundreds of thousands of vapers in the U.S. who did successfully quit smoking by switching to vaping. Survey data suggest that the actual number of ex-smokers who quit smoking by using e-cigarettes may be greater than a million, but even with the most conservative assumptions, no fewer than hundreds of thousands of ex-smokers quit thanks to vaping. But to the FDA, these people apparently do not exist.

The Rest of the Story

I have already explained why the abundant "anecdotal" evidence that e-cigarettes have helped hundreds of thousands of smokers to quit does constitute definitive support of e-cigarettes playing a cessation role. To ignore this evidence is to ignore the experiences of vapers throughout the United States and to deny their existence.

What an insult! It's like slapping these ex-smokers in the face and telling them that they don't count. Imagine if you told your doctor that you took up swimming and as a result you lost 15 pounds, and then your doctor responded, not by congratulating you, but by telling you there is no definitive evidence that swimming can help people lose weight. But you are that evidence.

It would have been one thing if the FDA had stated that there is not sufficient evidence to quantify the proportion of smokers who successfully quit using e-cigarettes or that we don't yet have enough clinical trial information to definitively compare the efficacy of e-cigarettes with that of nicotine replacement therapy or other smoking cessation drugs. But that's not what the FDA said. They said that there's no evidence that e-cigarettes play a role in smoking cessation.

That is quite obviously wrong. We know that e-cigarettes can and do play a role in smoking cessation. The question now is how big of a role? We have some idea of the number of smokers who quit by using e-cigarettes. What we don't know is how many smokers tried to quit using these products. Therefore, we can't quantify the proportion of quit attempts with e-cigarettes that were successful.

Unlike the FDA, I congratulate and applaud the vapers throughout the country who have been able to quit smoking using these products, as well as the vapers who have been able to reduce their cigarette consumption through dual use of e-cigarettes and tobacco cigarettes. Dual use, for many, is a pathway to complete smoking cessation and it has health benefits in terms of reducing the risk of cancer and lung disease as well as in lowering the level of nicotine addiction and making it easier to subsequently get off tobacco cigarettes altogether. Also unlike the FDA, I do not deny your existence or your experience. Instead, I value it because it lights a path forward for literally millions of smokers who have been unsuccessful in quitting using "FDA-approved" cessation methods.

Monday, August 01, 2016

Last month, the American Lung Association (ALA) issued a warning about "popcorn lung" (bronchiolitis obliterans), telling the public that electronic cigarettes can cause this severe disease because the aerosol contains diacetyl, a chemical that has been linked to the development of popcorn lung in highly exposed popcorn workers who were exposed to diacetyl present in the butter flavoring. The Lung Association's statement was entitled: "Popcorn Lung: A Dangerous Risk of Flavored E-Cigarettes."

According to the American Lung Association: "When inhaled, diacetyl causes bronchiolitis obliterans - more
commonly referred to as "popcorn lung" - a scarring of the tiny air sacs
in the lungs resulting in the thickening and narrowing of the airways.
While the name "popcorn lung" may not sound like a threat, it's a
serious lung disease that causes coughing, wheezing and shortness of
breath, similar to the symptoms of chronic obstructive pulmonary disease
(COPD). Even though we know that diacetyl causes popcorn lung, this chemical
is found in many e-cigarette flavors. It is added to "e-juice" liquid by
some e-cigarette companies to complement flavorings such as vanilla,
maple, coconut and more. So while diacetyl was swiftly removed from
popcorn products since it could cause this devastating disease among
factory workers, e-cigarette users are now directly inhaling this
harmful chemical into their lungs."

The Rest of the Story

It is important to consider not merely what the American Lung Association is telling you, but what they are not telling you.

While the ALA is warning the public that e-cigarette aerosol contains diacetyl and can cause popcorn lung, here is what they are not telling the public:

Cigarette smoke also contains diacetyl, but the average estimated daily exposure to diacetyl from smoking is about 750 times higher than that from vaping.

So why isn't the American Lung Association also warning the public that smoking can cause popcorn lung? And why aren't they calling on the FDA to require cigarette manufacturers to remove the diacetyl from their products?

Why the cover-up?

And by the way, this cover-up is not unique to the American Lung Association. I was unable to find a single anti-tobacco organization or health agency that is warning the public about the risk of popcorn lung from smoking or even mentioning that cigarette smoke contains high levels of diacetyl.

Sadly, this cover-up is having devastating consequences. For one, it is causing many smokers who were thinking about quitting to continue smoking instead. These smokers were scared away from switching to electronic cigarettes because they were frightened by the possible risk of developing popcorn lung. Clearly, had they known that the cigarette smoke they are inhaling exposes them to 750 times the amount of diacetyl than vaping does, this would have actually enhanced, rather than demolished, their incentive to quit smoking.

In addition, the cover-up is causing ex-smokers to return to smoking. These former smokers, who quit using e-cigarettes, are returning to smoking because they are frightened by the risk of popcorn lung. Again, had they known that the cigarette smoke they are inhaling exposes them to 750 times the amount of diacetyl than vaping does,
this would have enhanced, rather than demolished, their
chances of quitting smoking.

It is not entirely clear whether smoking itself causes popcorn lung in the first place. Pierce et al., in a 2014 article, noted that "smoking has not been shown to be a risk factor for bronchiolitis obliterans." However, since the symptoms of popcorn lung are similar to those of COPD, it may be that smokers who develop popcorn lung are thought to have COPD, so the popcorn lung is not diagnosed. If that is the case, then the risk of developing popcorn lung from smoking is still going to be astronomically higher than the risk of developing popcorn lung from vaping because the diacetyl exposure is so much higher.

Apparently, the anti-tobacco groups are on a mission to demonize electronic cigarettes, even if that comes at the expense of promoting cigarette smoking.

About Me

Dr. Siegel is a Professor in the Department of Community Health Sciences, Boston University School of Public Health. He has 32 years of experience in the field of tobacco control. He previously spent two years working at the Office on Smoking and Health at CDC, where he conducted research on secondhand smoke and cigarette advertising. He has published nearly 70 papers related to tobacco. He testified in the landmark Engle lawsuit against the tobacco companies, which resulted in an unprecedented $145 billion verdict against the industry. He teaches social and behavioral sciences, mass communication and public health, and public health advocacy in the Masters of Public Health program.